The European Medicines Agency (EMA) has released for comment a concept paper on the proposed revision of its “overarching” 2005 “similar biological” guideline to clarify concepts and provide updates that reflect how biosimilars are currently being developed by applicants. Comments are due by the end of February.
EMA notes in the introduction to the draft that “considerable experience has been gained on the concept of biosimilarity” through scientific advice procedures and approved marketing authorizations since the guideline came into force six years ago.
The proposed revision aims to: ● explain the principles of biosimilarity more clearly ● clarify what is meant by “biosimilar” or “similar biologic product ● discuss the legal basis for biosimilar products, and ● address “more specific aspects that require re-discussion and potentially a refinement,” including equivalence of efficacy and safety aspects.
The proposed guideline will replace the existing 2005 guideline on similar biological medicinal products, CHMP/437/04.
Regarding biosimilars in the US, FDA has released for comment a draft of its 2012-2017 performance goals for authorizing biosimilar products as called for under the terms of the Biologics Price Competition and Innovation Act of 2009 (IPQ “In the News” December 28, 2011).